ANDA 216229

ANNORA PHARMA

FDA Drug Application

Application #216229

Application Sponsors

ANDA 216229

ANNORA PHARMA

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	GRANULE;ORAL	180MG	0	DEFERASIROX	DEFERASIROX
002	GRANULE;ORAL	360MG	0	DEFERASIROX	DEFERASIROX

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-09-22

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

ANNORA PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216229
            [companyName] => ANNORA PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"DEFERASIROX","activeIngredients":"DEFERASIROX","strength":"180MG","dosageForm":"GRANULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DEFERASIROX","activeIngredients":"DEFERASIROX","strength":"360MG","dosageForm":"GRANULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/22\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-09-22
        )

)